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Longitudinal, Single-center Prospective Study to Assess Progression of Clinical Features and Biologic Markers of Parkinson's Disease Subjects of Varying Levels of Disease Severity

The primary objective of this study is to obtain detailed clinical information and biologic
specimens from subjects with PD toward the ultimate end of identifying a biomarker of PD.
Because of the inherent difficulties of using clinical outcome measures to assess disease
modification, the identification of biomarkers of PD is of paramount importance. The ideal PD
biomarker would be one that is easily assayed in a convenient biological sample, varies
proportionally with disease severity, is abnormal during the pre-symptomatic phase of the
illness, and is unaffected by drugs or other interventions used to treat PD. The existence of
a sensitive biomarker with these properties would enable much more effective disease
modifying research that would likely be able to take advantage of smaller and potentially
shorter trials.

Subjects will be asked to attend study visits every 6 months for up to 5 years of follow up.
Each visit will consist of patient outcomes questionnaires, neurological exams, computerized
assessments of gait and balance, a video recorded motor exam, and biological specimen
collection for biomarker discovery.

- For de-novo subjects: received any of the following drugs that might interfere with
dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa,
methylphenidate, reserpine, or amphetamine derivative, within 6 months of screening.

- For the prospective CSF cohort: current treatment with anticoagulants (e.g., coumadin,
heparin) that might preclude safe completion of the lumbar puncture.

- For the prospective CSF cohort: any condition that precludes the safe performance of
routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding
diathesis, or known clinically significant coagulopathy or thrombocytopenia.

- Any other medical or psychiatric condition or lab abnormality, which in the opinion of
the investigator might preclude participation.